Stimulation Device for Esophagus Might Ease GERD Symptoms

TUESDAY Oct. 23, 2012 -- Electric stimulation of the esophagus shows promise as a novel way to provide symptom relief for patients struggling with chronic gastroesophageal reflux (GERD), three new studies suggest.

The device's effectiveness, which was tested in very small groups of patients, was measured by two independent study teams -- one American and one Dutch.

Both teams presented their findings Monday at the American College of Gastroenterology annual meeting, in Las Vegas.

The goal: to develop a new therapy for GERD patients who are reluctant to undergo more invasive stomach surgery, or for whom a lifelong regimen of acid-suppression drugs known as proton pump inhibitors is either unappealing or not particularly effective.

"Most patients who have reflux symptoms are treated by meds that suppress acid production in the stomach," explained one of the American team's co-authors, Dr. Edy Soffer, director of the Gastro-Intestinal Motility Program with the Keck School of Medicine at the University of Southern California in Los Angeles. "They continue to reflux, but minus the acid."

"But there are a fair number that are not satisfied with the results," he noted, "because they continue to have symptoms or are concerned about taking medications for the rest of their lives."

"The established alternate option is surgery, in which the stomach is wrapped around the end of the esophagus to tighten it," Soffer explained. "But while it is effective, it is a very demanding procedure that has many potential side effects, such as trouble with swallowing and burping, diarrhea and sometimes the need for a secondary and more difficult 'redo' operation."

"The number of these surgeries has actually been declining over the past number of years, and there's a need for other solutions that provide better control than acid-control medication and fewer problems than the surgical option," he added.

With that in mind, Soffer and colleague Michael Crowell, of the Mayo Clinic in Scottsdale, Ariz., explored the potential of a new laparoscopic technique, in which a pair of small electrodes are inserted in the region of the lower esophageal sphincter where the stomach meets the esophagus. In turn, these electrodes are connected to a small stimulator device, fashioned along the lines of a heart pacemaker, that is implanted into the patient's abdominal wall.

Once in place, the device is designed to send low-energy pulses to the patient's poorly functioning lower esophageal sphincter (LES). The idea is to prompt this faulty valve, cited as the principle driving force behind GERD, into doing a better job of sealing off stomach acids from the esophagus.

In two studies -- one year-long study involving 19 patients and an ongoing two-year study involving 25 patients -- Soffer, Crowell and their colleagues tracked GERD symptoms after the procedure was done.

Following implantation, electrical stimulation therapy sessions were conducted for 30 minutes daily, and continued for a year.

After a year of therapy, patients in the first study appeared to experience a "normalization" of acid uptake in their esophagus. There were also no notable adverse reactions to the implant procedure or the stimulation therapy.

Among those in the second study, more than three-quarters of the patients similarly reported acid normalization or a 50 percent drop in their use of standard GERD medications by the end of the first year.

Although the second study has one more year to go, participants already were deemed to have experienced a "significant improvement" in their health-related quality of life.

The American team concluded that the electrical stimulation approach is effective as a treatment for GERD for at least one year after implantation.

The Dutch team, led by Dr. Arjan Bredenoord from the University Medical Center Utrecht in Rotterdam, came to a similar "preliminary" conclusion.

Their ongoing study involved 11 implantation patients, who have so far undergone electrical therapy for a period of between three and six months.

Apart from one patient dropping out, evaluations conducted at those three- and six-month marks have suggested that the approach does lead to "significant improvement" in terms of symptom relief, with no gastrointestinal side effects. As a result, all were able to stop taking the GERD medications they had been taking prior to implantation.

One expert was skeptical of the findings.

"There have a number of new techniques that have been explored in recent years," said Dr. Perry Milman, assistant clinical professor of medicine at the Albert Einstein College of Medicine, in New York City. "But with all the ones that we have seen, the statistics so far show that, invariably, after a year's period of time 50 percent of the patients who were able to successfully get off of their medications end up going back on them."

"I would also be hard-pressed to understand why a patient who would be reluctant to undergo standard stomach surgery would accept this kind of implantation technique," said Milman, who also is an adjunct assistant clinical professor of medicine at the State University of New York at Stony Brook, in Long Island. "You have something implanted into your abdomen that will involve anesthesia. And, really, anesthesia is the most invasive aspect of all these procedures."

"Regardless, the number of patients in these studies are very tiny, obviously," he added. "So I'm certainly not going to be running at this point to send anyone in for this. It's still way, way too early to say anything about this approach one way or another."

Although the device, known as EndoStim, was just approved for clinical use in the European Union, the procedure is not yet available to patients in the United States, where testing is still under way. Depending on further study results, Soffer suggested that the soonest it might be available for American GERD patients would be 2016.

But at what cost?

Although Soffer described the operation itself as a "simple, one-shot deal," it is not yet possible to itemize the full cost of the surgery and device. He did note, however, that the device would have a shelf life of about 10 years, much like most pacemakers, at which point replacement surgery would be required.

Funding for all the studies was provided by the manufacturer of the stimulation device, EndoStim BV, which is based in the Hague, The Netherlands. Data and conclusions presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

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